Promotion, Off-Label Communications, and First Amendment Concerns

September 28, 2018 10:15am

Alan G. Minsk
Partner
Arnall Golden Gregory LLP (Atlanta, GA)

  • Labeling, Advertising, and Promotion; Understanding FDA’s regulations and relevant guidances
  • Clarifying FDA’s current position on First Amendment and off-label promotion
  • What to expect concerning proposed legislation, rules changes and Citizen Petitions
  • Cases and Controversies: state AG actions and private tort claims